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Insertion Distance of Thoracic Epidural Catheters in the Context of Thoracotomy Procedures.

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ClinicalTrials.gov Identifier: NCT00754195
Recruitment Status : Completed
First Posted : September 17, 2008
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

This study is designed to compare thoracic epidural catheter insertion distances, in order to determine which is the best for pain relief following a thoracotomy.

HYPOTHESIS :

  1. The quality of epidural analgesia upon coughing one hour following the end of surgery will not be inferior if the catheter is inserted 7 cm in the epidural space, versus 3 and 5 cm.
  2. The quality of epidural analgesia upon coughing at 24 hour will not be inferior if the catheter is inserted 3 cm in the epidural space, versus 5 and 7 cm.

Condition or disease Intervention/treatment Phase
Pain Other: Thoracic epidural catheter Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Catheter Insertion Distance on the Quality of Thoracic Epidural Analgesia in the Context of Thoracotomy Procedures.
Study Start Date : September 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Active Comparator: 1
Insertion distance of thoracic epidural catheter: 3 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.

Active Comparator: 2
Insertion distance of thoracic epidural catheter: 5 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.

Active Comparator: 3
Insertion distance of thoracic epidural catheter: 7 cm
Other: Thoracic epidural catheter
Comparison of 3 insertion distances (3,5 and 7 cm) for a thoracic epidural catheter in the context of thoracic surgery.




Primary Outcome Measures :
  1. Quality of pain relief during cough [ Time Frame: At one hour and 24 hours after surgery ]

Secondary Outcome Measures :
  1. Quality of pain relief at rest [ Time Frame: At one hour and 24 hours after surgery ]
  2. Proportion of failed epidurals [ Time Frame: At one hour and 24 hours after surgery ]
  3. Wound palpation pain [ Time Frame: At one hour and 24 hours after surgery ]
  4. Loss of cold sensation around the wound [ Time Frame: At one hour and 24 hours after surgery ]
  5. Cumulative bupivacaine and morphine consumption [ Time Frame: At one hour and 24 hours after surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 years and older undergoing an elective thoracotomy.

Exclusion Criteria:

  • Infection or sepsis
  • Coagulopathy
  • Hypovolemia
  • Allergy to local anesthetics
  • Neuropathy that could affect study assessments
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754195


Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Principal Investigator: Stephan R Williams, MD, PhD Centre hospitalier de l'Université de Montréal (CHUM)

Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT00754195     History of Changes
Other Study ID Numbers: 08.071
First Posted: September 17, 2008    Key Record Dates
Last Update Posted: February 23, 2015
Last Verified: February 2015

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Thoracotomy